Reported May 1, 2019 · Terminated
St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile. Product Usage: The St. Jude Medical…
Abbott
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Abbott · 15900 Valley View Ct · Sylmar, CA · 91342-3577
Is this the product you have?
- St. Jude Medical Confirm Rx Insertable Cardiac Monitor, REF DM3500, Sterile
- Product UsageThe St. Jude Medical Confirm Rx insertable cardiac monitor (ICM) is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network (PCN). It is indicated for the monitoring and diagnostic evaluation of patients who
- experience unexplained symptoms such asdizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation
- Lot codes and dates
Serial numbers 9225191922450192251799225193922520792422099257638925764692576569257659922450892244909224503922452592245299225190922520392252059225208922521192252149225851922585592258589225859922586792258689242199924221992422259242231and 9256057
- Amount recalled
- 32 devices
Where it was sold
Why it was recalled
The device is unable to pair with the mobile app due to the device incorrectly determining the certificate has expired.
This product could cause temporary or reversible health problems — stop using it.
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